All health supplements imported into China need to be registered with a Health Food Registration Certificate or Health Food Filing Certificate before they can be sold in China. Approval path defines the testing, documentation, timelines, and regulatory aspects for entering the market. The Health Supplements Regulations in China are detailed in this guide, including the registration process, documentation, labelling, import requirements, and compliance obligations.
Regulatory Authority for Health Supplements in China
The State Administration for Market Regulation (SAMR) is the most important regulatory body for Health Supplements (Health Foods) in China. SAMR is responsible for Health Food Registration, Health Food Filing, and post-market supervision. All health supplements must have a Health Food Registration Certificate or Health Food Filing Certificate in order to be sold in China.
What Are Health Supplements Under Chinese Regulations?
Health supplements are regulated as Health Foods in China. These products may be used to supplement vitamins and minerals or to make a scientifically substantiated health claim, but are not intended to diagnose, treat, cure or prevent diseases. Products can be filed as a Health Food or registered as a Health Food, depending on the ingredients and claims.
Compliance Checklist for Health Supplement Approval in China
Prior to applying for Health Food Registration or Filing in China, companies are advised to ensure that:
- The product is in line with Chinese health food regulations.
- Ingredients meet China’s requirements for Health Food ingredients.
- The claimed health benefits are allowed.
- Product testing can be carried out.
- Labels and packaging meet China’s labelling regulations.
- A Chinese agent or representative is hired for imported products.
- All necessary documents are ready for submission.
Health Supplements Registration Process in China
Health supplements are required to go through the Health Food Filing and/or Health Food Registration process in order to be sold in the Chinese market. Here is the step-by-step approval process.
Step 1: Check if the Product Needs Filing or Registration
Products with health function claims or products not included in the directories approved by the Chinese government require Health Food Registration. Imported vitamin and mineral supplements that meet the Chinese-approved ingredient directories may be considered for Health Food Filing.
Step 2: Choose a Chinese Agent
Foreign manufacturers should find a Chinese agent to make the application and communicate with the authorities during the application process.
Step 3: Conduct Product Testing and Compliance Assessment
Ingredients should be checked for compliance, health claims evaluated, and necessary safety, quality and stability testing should be carried out. Further technical assessment may be needed for some products.
Step 4: Prepare a Registration or Filing Dossier
Application forms, formulation information for the product, manufacturing details, testing reports, safety data, quality documents, and labelling materials are generally among the documents in the dossier. Imported products will require supporting documents from the country of origin as well.
Step 5: Submit the Application to SAMR
Applications for imported health supplements are made to SAMR via the appropriate filing or registration process.
Step 6: Complete Regulatory Review
SAMR will conduct an application review and may seek additional information as part of the review.
Step 7: Obtain Approval
After approval, SAMR will issue a Health Food Registration Certificate or Health Food Filing Certificate.
Documents Required for Health Supplements Registration in China
Typical application documents are:
- Health Food Registration/Filing Application Form
- Legal Responsibility Commitment Letter
- Information on the applicant and manufacturer
- Business registration certificates
- Authorisation letter for a Chinese agent
- Product formulation and ingredient specifications
- Manufacturing process information
- Product quality standards
- Safety assessment reports
- Product testing reports
- Stability study data
- Scientific evidence supporting health claims
- Product labels and packaging artwork
- Product instructions for use
- Proof of legal sale in the country of origin
- Manufacturing or quality management documents
Note: All documents in other languages must be translated into Chinese before submission.
Labelling Requirements for Health Supplements in China
If they are to be marketed, Health Foods need to meet China’s labelling requirements. Labels are required to be in Chinese and match the approved registration or filing information.
- Product name
- Blue Hat logo
- Registration or filing number
- Ingredients list
- Net content
- Usage instructions
- Suitable and unsuitable populations
- Storage conditions
- Manufacturer information
- Required statement: “This product is not a substitute for medicine.”
Licensing Requirements for Health Supplements in China
In order to sell a health supplement in China, imported health supplements must obtain a Health Food Registration Certificate or a Health Food Filing Certificate.
In order to receive approval, companies are required to:
- Determine whether the product is eligible for Filing or Registration
- Engage a Chinese agent or representative
- Submit the required dossier
- Complete product testing and review
- Obtain approval before importation and commercialisation
Health Food Registration Certificates and Health Food Filing Certificates are issued to approved products.
GMP Requirements for Health Supplements in China
Some imported products might need to submit manufacturing and quality management documents during registration, such as:
- GMP certificate (if available)
- Manufacturing process information
- Quality control procedures
- Product specifications
Health Claims and Advertising Regulations in China
China only allows approved Health Food claims and does not allow disease-related claims. Advertising content must be in accordance with the approved registration or filing information.
- Only approved health claims are permitted.
- No disease prevention or treatment claims are allowed
- Approved claim wording must be used
- “This product is not a substitute for medicine” is mandatory
Import Regulations for Health Supplements in China
Health supplements must be imported with a Health Food Registration Certificate or Health Food Filing Certificate. Overseas manufacturers may need GACC registration before exporting products to China.
- Obtain Health Food Registration or Filing approval.
- Appoint a Chinese agent or importer
- Complete GACC registration (if applicable)
- Ensure Chinese-compliant labeling
- Fulfil Chinese food safety requirements
Health Supplement Registration Timelines in China
The approval timeline depends on the product type and approval pathway.
- Health Food Filing: generally faster than Registration
- Health Food Registration: typically, 1–3 years
- Additional testing or information requests can extend timelines
- Products containing non-directory ingredients generally require longer review periods
Health Supplement Registration Costs in China
The cost of Health Supplement Registration in China depends on the approval pathway and product requirements. There is generally an increase in registration costs due to additional testing and technical review requirements.
Key cost drivers include:
- Product testing
- Stability studies
- Toxicology studies (if required)
- Dossier preparation and translation
- Chinese agent fees
- Additional information requests during the review process
Products eligible for Registration generally incur higher costs than products eligible for Filing.
Conclusion
Imported health supplements must obtain either a Health Food Registration Certificate or a Health Food Filing Certificate before they can be marketed in China. Determining whether a product qualifies for Filing or requires Registration is the first step in developing an effective China market entry strategy.
Partnering with an expert can help you go through the regulatory process smoothly. With Artixio, product registration in China becomes simpler as our team ensures end-to-end compliance. To know more, get in touch with us at info@artixio.com.
FAQs
What is the difference between Health Food Registration and Filing in China?
Health Food Filing is generally available for eligible vitamin and mineral supplements, while products with functional health claims or non-directory ingredients typically require full Health Food Registration.
How long does Health Supplement Registration in China take?
Health Food Filing is generally faster than Registration, while Health Food Registration can take 1–3 years, depending on testing and review requirements.
Can foreign companies apply for Health Supplement Registration in China?
Yes. Foreign manufacturers can apply, but they must appoint a Chinese agent to manage the registration or filing process.
Is the Blue Hat logo required for Health Foods in China?
Yes. Approved Health Foods must display the Blue Hat logo and the corresponding registration or filing number on the product label.
